Quality Control Analyst II

About the role

As a Quality Control Analyst II, you will perform compendial assessments to ensure compliance with current regulatory requirements and pharmacopeial standards. You will author and review technical documents, including protocols, standard operating procedures (SOPs), and analytical methodologies and design and coordinate analytical method onboarding activities, including execution planning, training, and documentation.

Responsibilities

• Lead and manage the qualification of critical materials, ensuring fitness for use in analytical testing.
• Oversee change control management processes, including risk assessment, documentation, and implementation.
• Manage Corrective and Preventive Actions (CAPAs) related to analytical processes and support timely closure of quality events.
• Act as a Subject Matter Expert (SME) by providing technical guidance and troubleshooting support to laboratory testing teams.
• Collaborate effectively across departments to ensure alignment and successful execution of cross-functional initiatives.
• Identify and drive continuous improvements in analytical methods and laboratory workflows to enhance efficiency and compliance.
• Conduct data trending and analysis of laboratory processes and analytical performance on a routine basis to identify trends and areas for improvement.
• Collaborate as a QC representative with global teams on both global and local projects and take the initiative for improvements.

Requirements

• Bachelor's degree in Chemistry, Biology, Microbiology, Engineering, or another scientific discipline with 2–5 years of experience in pharmaceutical, biotechnology, or other GMP-regulated laboratory environments.
• Experience supporting laboratory quality systems, including change controls, CAPAs, investigations, and technical documentation.
• Knowledge of analytical method lifecycle activities, including method implementation, onboarding, validation, or transfer.
• Strong understanding of cGMP regulations, laboratory compliance, and pharmaceutical quality systems.
• Experience performing statistical analysis, data trending, and process monitoring using tools such as Microsoft Excel or Minitab.
• Experience with environmental monitoring programs or laboratory quality metrics is preferred.
• Familiarity with digital tools such as Power BI, Power Automate, or similar data visualization and workflow automation platforms is a plus.
• Excellent project management, organizational, and technical writing skills with the ability to manage multiple priorities simultaneously.
• Strong communication and collaboration skills with demonstrated success working across Quality Control, Manufacturing, Engineering, Validation, and Regulatory teams.
• Self-motivated professional who thrives in a fast-paced laboratory environment and enjoys driving continuous improvement initiatives.

Qualifications

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body.
• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

Skills

• Strong understanding of cGMP regulations, laboratory compliance, and pharmaceutical quality systems.
• Experience performing statistical analysis, data trending, and process monitoring using tools such as Microsoft Excel or Minitab.
• Experience with environmental monitoring programs or laboratory quality metrics is preferred.
• Familiarity with digital tools such as Power BI, Power Automate, or similar data visualization and workflow automation platforms is a plus.
• Excellent project management, organizational, and technical writing skills with the ability to manage multiple priorities simultaneously.
• Strong communication and collaboration skills with demonstrated success working across Quality Control, Manufacturing, Engineering, Validation, and Regulatory teams.

Benefits

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Pay

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

Schedule

Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.